DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

March 23, 2021 updated by: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Diffusion-weighted Images as an Additional Method for Diagnosing Histological Types of Nephroblastoma in Children

Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps. Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2.

After the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner, using 8-channel body coil. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps (DWI 3b) with 3 b-factors (50; 600; 800 or others, optional). Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2. The values are entered in the table due to the stage of the chemotherapy.

After the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated.

Study Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 days to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age under 18 y.o.;
  2. Renal mass with confirmed histology.

Exclusion Criteria:

  1. Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);
  2. Refusal to sign the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
Time Frame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
Point 1. 15 ± 3 days Before the start of therapy - the starting point.
To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
Time Frame: Point 2. after pre-operative chemotherapy up to 1 week
Point 2. after pre-operative chemotherapy up to 1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the reproducibility and compatibility of the ADC values measurement;
Time Frame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
Point 1. 15 ± 3 days Before the start of therapy - the starting point.
To evaluate the reproducibility and compatibility of the ADC values measurement;
Time Frame: Point 2. after pre-operative chemotherapy up to 1 week
Point 2. after pre-operative chemotherapy up to 1 week
To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;
Time Frame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
Point 1. 15 ± 3 days Before the start of therapy - the starting point.
To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;
Time Frame: Point 2. after pre-operative chemotherapy up to 1 week
Point 2. after pre-operative chemotherapy up to 1 week
To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children
Time Frame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
Point 1. 15 ± 3 days Before the start of therapy - the starting point.
To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children
Time Frame: Point 2. after pre-operative chemotherapy up to 1 week
Point 2. after pre-operative chemotherapy up to 1 week
To assess the ADC values change in depending according to the provided chemotherapy.
Time Frame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
Point 1. 15 ± 3 days Before the start of therapy - the starting point.
To assess the ADC values change in depending according to the provided chemotherapy.
Time Frame: Point 2. after pre-operative chemotherapy up to 1 week
Point 2. after pre-operative chemotherapy up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Investigators

  • Study Director: Galina f Tereshchenko, PhD, Chief radiology department at Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2020

Primary Completion (ANTICIPATED)

December 21, 2023

Study Completion (ANTICIPATED)

December 21, 2023

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCPHOI-2019-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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